Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00452803

Last Updated: 2010-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-12-31

Brief Summary

It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.

Detailed Description

Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8 Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles

Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 & 29 Cisplatin (20 mg/m2)on day 1, 8, 15, 22 & 29. Thoracic radiation therapy (TRT) 1.8 Gy daily, five times per week (45 Gy target dose in 5 weeks).

Postoperative Consolidation Chemotherapy:

Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2 cycles

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study arm

pre-operative chemotherapy (Pac/Cis)

Group Type: ACTIVE_COMPARATOR

chemotherapy

Intervention Type: DRUG

Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

study arm 2

Pre-operative concurrent chemoradiation therapy

Group Type: ACTIVE_COMPARATOR

Concurrent chemoradiation therapy

Intervention Type: DRUG

Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

Concurrent chemoradiation therapy

Intervention Type: RADIATION

Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Interventions

chemotherapy

Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

Intervention Type: DRUG

Concurrent chemoradiation therapy

Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

Intervention Type: DRUG

Concurrent chemoradiation therapy

Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Histologic or cytologic diagnosis of non-small cell lung cancer.

2. Presence of biopsy-proven N2 stage IIIA, according to the American Joint Committee on Cancer (AJCC), with none of the mediastinal lymph nodes > 3 cm in largest diameter.

3. Tumor amenable to surgical resection.

4. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).

5. No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).

6. Performance status of 0-1 on ECOG scale.

7. At least 18 years old.

8. Patient compliance that allows adequate follow-up.

9. Medical fitness of patients adequate for radical NSCLC surgery.

10. Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ≥ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.

11. Signed informed consent from patient or legal representative.12. Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.

Exclusion Criteria

1. Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.

2. Active uncontrolled infection.

3. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.

4. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.

5. Significant neurological or mental disorder.

6. Second primary malignancy.

7. Pregnant or nursing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

National Cancer Center, Korea

Principal Investigators

Heung Tae Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Heung Tae Kim, M.D.

Role: CONTACT

htkim@ncc.re.kr

+82-31-920-1602

Other Identifiers

NCCCTS-06-164

Identifier Type: -

Identifier Source: org_study_id